ObesityOSVNCT02326480
Genetic Analysis of Childhood Obesity
An observational study of Obesity, run by Lille Catholic University at 1 site in France.
Trial summary
Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Identification of genetic causes of obesity
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Three categories of obese children with their biological parents will be included (syndromic, familial, isolated obesity).
Who may be able to join
- BMI > curve of IOTF 30 (International Obesity Task Force)
- Age: between 6 months old and 18 years old
- Child presenting syndromic, isolated or familial obesity.
Who cannot join
- Common obesity
- Impossibility for blood sampling
- Impossibility to receive information
- Participation refusal of one of the parents
- Refusal to sign the informed consent
- Neither Healthcare coverage nor insurance
Trial locations and contacts
1 site in 1 country.
Amélie Lansiaux, MD, PhD contact
Mélanie Hamez contact
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Vincent de Paul
Lille
Louise Montagne
About this study
Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes
- Conditions
- Obesity
- Being tested
- Identification of genetic causes of obesity
- Keywords
- Childhood Obesity, Genetics
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of genetic causes of obesityOther
A blood test will be performed to the child and his/her parents with the aim of identifying genetic causes of obesity. Different analysis will be as follows: caryotypes, Raindance, whole exome, in order to find potential mutations or new genes associated to this condition
| Study group | Role | What they receive |
|---|---|---|
| Syndromic obesity | Identification of genetic causes of obesity | |
| Familial obesity | Identification of genetic causes of obesity Receives: Other: Identification of genetic causes of obesity | |
| Isolated obesity | Identification of genetic causes of obesity Receives: Other: Identification of genetic causes of obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the number of mutations or genes involved in genetic causes of Child obesity
Children with obesity and their parents will be recruited to establish genetic causes of obesity. This will allow perform genetic analysis using new approaches for the identification of involved mutations or new candidate genes
Measured: first day of enrollement
Secondary outcomes (3)
To identify the number of mutations in the population
Measured: first day of enrollement
To identify the number of new mutations present in the children's DNA and absent from their parents' genomes
This approach will allow the identification of specific mutations that are present only in affected children but not in their parents
Measured: first day of enrollement
To determine number of phenotypes associated to the child obesity genotype
Measured: first day of enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Responsible party
- Sponsor
- Investigators
- Louise Montagne, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de LillePhilippe Froguel, MD, PhD, Principal investigator, UMR CNRS 8199, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326480
- Sponsor's protocol ID
- RC-P0036
- Acronym
- OSV
- Status last verified
- Mar 2020
- First submitted
- 15 Dec 2014
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Childhood Obesity
- ClinicalTrials.gov ID
- NCT02326480
- Acronym / sponsor ID
- OSV / RC-P0036
- Conditions
- Obesity
- Keywords
- Childhood Obesity, Genetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille
- Study start
- Jan 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Syndromic obesity | – | –Identification of genetic causes of obesity |
| Familial obesity | – | Other: Identification of genetic causes of obesityIdentification of genetic causes of obesity |
| Isolated obesity | – | Other: Identification of genetic causes of obesityIdentification of genetic causes of obesity |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Three categories of obese children with their biological parents will be included (syndromic, familial, isolated obesity).
Key inclusion criteria (3 listed)
- BMI > curve of IOTF 30 (International Obesity Task Force)
- Age: between 6 months old and 18 years old
- Child presenting syndromic, isolated or familial obesity.
Key exclusion criteria (6 listed)
- Common obesity
- Impossibility for blood sampling
- Impossibility to receive information
- Participation refusal of one of the parents
- Refusal to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of genetic causes of obesityA blood test will be performed to the child and his/her parents with the aim of identifying genetic causes of obesity. Different analysis will be as follows: caryotypes, Raindance, whole exome, in order to find potential mutations or new genes associated to this condition | Other | Familial obesity, Isolated obesity |
Primary outcome
To identify the number of mutations or genes involved in genetic causes of Child obesity
Time frame: first day of enrollement
Children with obesity and their parents will be recruited to establish genetic causes of obesity. This will allow perform genetic analysis using new approaches for the identification of involved mutations or new candidate genes
3 secondary outcomes
To identify the number of mutations in the population
Time frame: first day of enrollement
To identify the number of new mutations present in the children's DNA and absent from their parents' genomes
Time frame: first day of enrollement
To determine number of phenotypes associated to the child obesity genotype
Time frame: first day of enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amélie Lansiaux, MD, PhD contact
Mélanie Hamez contact
Louise Montagne principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
Philippe Froguel, MD, PhD principal investigator
UMR CNRS 8199, Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, MD, PhD (lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the number of mutations or genes involved in genetic causes of Child obesity (time frame: first day of enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.